JP2015530127A - Method for operating a graphical 3D computer model of at least one anatomical structure with selectable preoperative, intraoperative or postoperative status - Google Patents

Abstract

The present invention relates to a method for generating a graphical 3D computer model of an anatomical structure with selectable pre-operative, intra-operative or post-operative status and comprises the following steps. A) receiving a preoperative first medical 3D image data set (10) of the anatomical structure to be treated by the computer-assisted medical imaging method; B) receiving the first received in step A). Generating a first graphical 3D computer model (1) of the anatomy to be treated in the form of a digital data set using one medical 3D image data set (10), C) a computer assisted medical image Depending on the digitization method, receiving a second medical 2D or 3D image data set (20) of the anatomy to be treated in pre-operative, intra-operative or post-operative status, D) received in step C) A second group of anatomical structures to be treated in the form of a digital data set using a second medical 2D or 3D image data set (20). Generating a physical 2D or 3D computer model (2), E) performing an image registration process of the first graphical 3D computer model (1) using the second graphical 2D or 3D computer model (2) .

Description

  The invention relates to a method for generating a graphical three-dimensional (3D) computer model of at least one anatomical structure with selectable pre-operative, intra-operative or post-operative status according to the preamble of claim 1.

  With surgical treatment of fractures and correction of bone misalignment, the bone fragments are anatomically reduced to the correct position and fixed in a stable manner using appropriate osteosynthesis. However, problems can arise from undetected incorrect positions of bone fragments and implants during the course of surgery, or secondary dislocations during the post-operative course. Accordingly, incorrect osteosynthesis due to anatomically incorrect reduction of bone fragments, incorrect surgical technique, improper implant selection and / or their positioning should be avoided.

  Fractures and bone misalignments are evaluated or scheduled as prescribed by various radiological imaging processes before, during and after surgery. Usually, these procedures include obtaining conventional x-rays, ie, planar projection displays. In particular, complex therapeutic interventions are evaluated using computed tomography (CT), preferably using tomographic imaging displays. This is done by analyzing the cross-sectional image or the three-dimensional computer model, preferably pre-operatively, and in the case of special problems, during or after the operation.

  However, the date of bone fragments and osteosynthesis cannot be spatially evaluated in the final way during routine clinical operations of the entire course of treatment. To accomplish this, a 3D imaging process such as CT may be required at all of the treatment steps. As mentioned, this is technically possible in practice, but so far costs, radiation hygiene reasons, artificial generation, and costs for personnel, tissue, and technology have been At every stage, there is a clear issue for the regulatory spatial assessment of osteosynthesis.

  A method for the reduction of fractured bone fragments is known from US Pat. Appl. No. 2011/0082367 by Regazzoni. This known method involves the generation of 3D representations of bones and bone fragments based on digital data sets obtained by CT of the healthy bones on the contralateral side of the patient as well as fractured bones, and mirrored contralateral The 3D representation of healthy bone is used as a reference model for the relative position of the 3D representation of the reduced bone fragment. A 3D representation of the proximal and distal bone fragments is then performed in each case by 3D image registration to match the 3D representation of the reference model, and the shape of the marker or anatomical landmark is Extracted with proximal and distal bone fragments and transferred to reference model. The relative position of the proximal and distal bone fragment markers or anatomical landmarks transferred to the reference model is then used to prepare a digital reference data set that can be used for actual reduction of the bone fragment during surgery. It is possible. Using a C-arm fluoroscope, in each case two in situ medical images of the patient's proximal and distal bone fragments positioned on the operating table are acquired preoperatively. From each of the two medical images, the next three-dimensional position of the proximal and distal bone fragment markers or anatomical landmarks is calculated relative to the local coordinate system, from which the proximal and distal The relative original position of the marker or anatomical landmark of the distal bone fragment is calculated. Finally, a set of alignment parameters is identified by comparing the relative reference positions of the digital reference data set and the marker or anatomical landmark.

  This known method does not require image registration of in-situ medical images acquired pre-operatively using a 3D representation of the bone or bone fragment used for planning. However, because such image registration is not performed, the surgical steps, implants, and surgical instruments determined during planning cannot be moved to their original state.

  Proper anatomical reduction of bone fragments, including stable osteosynthesis, is a major surgical concept in fracture treatment and corrective osteotomy. However, this is not easy to achieve in particularly difficult situations, such as joint fractures or complex orthopedic osteotomy. In principle, errors may occur during surgery or only during the postoperative course. One possible cause of the error occurs when bone reduction was actually stable but performed in an anatomically incorrect manner and this was not detected during surgery. Moreover, even if the skeleton can actually recover properly, the implant will be placed in an incorrect position that is not detected, eg, the joint gap. Biomechanically inadequate osteosynthesis and / or osteosynthesis with dislocation of the bone defect is usually manifested only during the postoperative course.

  Therefore, both in the treatment of fractures and in the case of bone misalignment, osteosynthesis consisting of bone fragments and implants needs to be better shown and planned preoperatively, and moreover, By monitoring the construct, there is a need for better monitoring during and after surgery in the sense of space, in other words 3D.

US Patent Application Publication No. 2011/0082367

  The present invention provides a method for generating a graphical 3D computer model that includes at least an anatomical structure to be treated or treated in selectable preoperative, intraoperative, or postoperative status. And can be used to control or monitor planned therapeutic interventions such as orthopedic surgery. For example, insertion of dental implants or other therapeutic interventions such as, for example, neurosurgical interventions can be monitored in the same manner.

  The present invention solves the problems posed by the method for generating a graphical 3D computer model having the features of claim 1.

  The advantage achieved by the present invention is that, for the method according to the present invention, an initially generated 3D computer model of an anatomical structure such as, for example, a bone is now further added to a conventional preoperative X-ray image, Consider that it can always be represented spatially throughout the entire course of treatment by repeated registration using various imaging processes such as intraoperative planar 2D C arc or spatial 3D C arc images, or post-operative X-ray images Is done. The spatial representation generated by CT once and preferably pre-operatively is advantageous for several reasons, such as generating a spatial representation of the area to be treated at the start of treatment. This spatial information can then be used for diagnosis and treatment planning. Moreover, more time can be used before surgery, for example, to process and analyze information than during surgery. In addition, for time-related and / or technical reasons, other imaging processes that generate images by intraoperative 2D or 3D C-arc imaging generate 3D computer models of anatomical structures such as bone Because of its less appropriateness, it is not necessarily suitable. The same is true for conventional pre- and post-operative x-rays, which cannot be represented to the scale of a 3D computer model of an anatomical structure such as a bone fragment, or in any case without significant additional cost. The same applies to images. These X-ray images represent a plane addition image generated only from a single projection direction. However, high image resolution is an advantage.

Definition:
Medical 3D image data set: It is an advantage that a medical 3D image data set of the anatomy to be treated of a patient, for example an area with fracture or bone misalignment, is acquired by CT. Alternatively or additionally, other three-dimensional tomographic imaging processes such as cone beam tomography (also called digital volume tomography), magnetic resonance tomography, or even 3D laser scanning may be used.

  Medical 2D image data set: The term medical 2D image data set refers to a digital data set that includes digital data of one or more digitized planar x-ray images of the anatomy to be treated of a patient. .

  Graphical 3D computer model: The term graphical 3D computer model is an object that can be represented on a monitor and is defined by a digital data set, such as anatomy, temporary (eg, surgical instruments and tools), and implants. Points to the virtual model. The first graphical 3D computer model may include several extractable graphical 3D submodels of individual anatomical structures, eg, bone fragments, one or more implants, and / or one or more surgical instruments. . In addition, a second graphical 2D or 3D computer model may be used to extract several anatomical structures such as bone fragments, one or more implants and / or several extractable graphical 3D sub-sections of one or more surgical instruments. It is also possible to include a model.

  Implant: The term implant is usually a conventional X-ray image, CT, or magnetic resonance tomography (MRI) that is artificially, wholly or partially inserted or inserted into the human or animal body. Refers to any solid means that changes only to a limited extent in terms of shape, such as an orthopedic implant, a dental implant, a cardiac pacemaker, or a stent.

  Image registration: The term “image registration” below refers to the superposition of two or more 2D representations of the anatomy to be treated and / or the implant used, Created to exactly match the graphical 3D computer model of the anatomy and / or implant to be defined and defined in each case by a digital data set.

  In the method according to the invention, using image registration, one or more digitized medical images of a second medical 2D or 3D image data set of the anatomy and / or implant to be treated are first Aligned using a graphical 3D computer model, so that the updated location of the first graphical 3D computer model, i.e., the anatomical structure and / or implant to be treated, preoperative, intraoperative, or surgical A position adapted to the later position can be represented on a computer monitor.

  Additional advantageous embodiments of the present invention can be commented as follows.

  In a special embodiment of the invention, step B) further comprises the following substeps.

  B1) Introducing a digital graphical 3D sub-model that represents the implant in a first graphical 3D computer model.

  The graphical 3D submodel of the implant can be copied from a database, such as a CAD database, to the first graphical 3D computer model.

  In another embodiment of the invention, step B) additionally includes the following substeps:

  B2) Introducing a digital graphical 3D sub-model that represents the surgical instrument in a first graphical 3D computer model.

  The graphical 3D submodel of the surgical instrument can be copied from a database, such as a CAD database, to the first graphical 3D computer model.

  In another embodiment of the method, the first medical 3D image data set received pre-operatively in step A) includes a number of anatomical structures, and the first graphical 3D computer model is used for each anatomy. A graphical 3D sub-model is included in each case for each implant and / or for each surgical instrument. In this way, it is possible to achieve the advantage that a graphical 3D sub-model that can be acquired separately can be integrated with the first graphical 3D computer model with respect to the anatomy to be treated, eg bone or bone fragment Possible, so that individual analysis of specific anatomical structures is possible. Moreover, the first graphical 3D computer model can obtain a graphical 3D submodel of implants and surgical instruments that can be acquired separately.

  In another embodiment of the present invention, the second graphical 2D or 3D computer model additionally includes a representation of one or more implants.

  In yet another special embodiment of the method, the second graphical 2D or 3D computer model additionally includes a representation of one or more surgical instruments.

  In another embodiment of the method, the anatomical structure and each implant, and preferably the second graphical 2D or 3D computer model of each surgical instrument, in each case includes a graphical 2D or 3D sub-model. It is out.

  In yet another embodiment of the method, the second graphical 2D or 3D computer model forms a reference model that is performed to overlap the first graphical 3D computer model in performing the image registration. The second graphical 2D or 3D computer model is used as a reference model, so it defines the target model, along with which the first graphical 3D computer model (object model or source model) is performed simultaneously. The reception of the second medical 2D or 3D image data set may include one or more digitized medical images, acquired at a predetermined angle of the image plane of the C-arm X-ray device with respect to the gravity vector, As a result, the position of the anatomical structure to be treated, and thus the position of the first graphical 3D computer model, is defined in a coordinate system fixed relative to the operating room.

  In an additional embodiment of the method, the reception of a second medical 2D or 3D image data set in step C) (in pre-operative, intra-operative or post-operative status) 1 by a computer-assisted medical imaging process Including reception of one or more digitized medical images. When two or more digitized medical images are acquired at a fixed angle relative to each other, a 3D computer model can be generated. On the other hand, various fragments and / or sections of long bones can each be represented for one of the digitized medical images, so that C-arm X-rays with a display of a relatively small field used during surgery. The device can be used to receive a second medical 2D or 3D image data set. The method is characterized in that at most one X-ray display is sufficient and can eliminate the "two-sided" standard display known to those skilled in the art. Thus, an additional advantage of the method is reduced exposure to radiation and reduced cost. In the case of fracture treatment and corrective osteotomy, the entire osteosynthesis construct consisting of bone fragments, possibly remaining bone defects, and used implants can be evaluated spatially throughout the course of treatment. The computer monitor makes it possible to visualize 3D computer models of anatomical structures such as fractures or osteotomy, depending on the stage of treatment, which can be followed by follow-up bones before, during and after surgery. Express spatially. Here, 3D imaging is only required once. As soon as the implant material becomes radiologically visible, its position is also determined spatially and expressed, for example, using a 3D computer model of an anatomical structure such as a bone fragment and referring to that 3D computer model. obtain.

  In yet another embodiment of the method, the generation of the first graphical 3D computer model includes automatic or manual identification and identification of anatomical landmarks, lines, and / or regions of the anatomy to be treated. Contains.

  In another embodiment of the method, the generation of the first graphical 3D computer model includes automatic or manual identification and identification of each implant and preferably each surgical instrument landmark, line, and / or region. Yes.

  In another embodiment of the method, the generation of the second graphical 2D or 3D computer model is identified with the first graphical 3D computer model and identified anatomical landmarks, lines of anatomy to be treated And / or automatic or manual re-identification or re-identification of the area. Thus, in the simplest case, the second graphical 2D or 3D computer model contains a single digitized medical image with re-identified and re-specified anatomical landmarks. Thus, image registration can be performed by a landmark-based registration process. In the landmark-based registration process, a certain number, generally a relatively small number, of landmarks, eg, anatomical landmarks, are extracted from the image. This occurs either manually or automatically. The selected anatomical landmarks are preferably distributed to the extent possible in the image and are not concentrated only in individual areas. Then, for example, the anatomical landmark selected in the object model, i.e. the landmark selected in the first graphical 3D computer model, is on the reference model or target model, i.e. the second graphical 2D or 3D computer model. Image registration is performed at points resulting from the same anatomical landmarks. In addition to anatomical landmarks, image surfaces that are clearly visible from surrounding surfaces, in other words, region landmarks or lines or edges that themselves are presented as region lines or contours are also used as landmarks. obtain. Lines can also be represented and extracted using, for example, end points.

  In another embodiment of the present invention, each implant and each surgical instrument landmark, line, and / or generation of the second graphical 2D or 3D computer model identified and identified in the first graphical 3D computer model Includes automatic or manual re-identification or re-identification of regions.

  Registration of the graphical 3D sub-model of the implant and / or surgical instrument can be done in two ways:

1) First, the graphical 3D submodel of the anatomy of the first graphical 3D computer model is aligned using the graphical 3D submodel of the anatomy of the second graphical 3D computer model, and then A graphical 3D sub-model anatomical in which the first graphical 3D computer model implant and / or the surgical instrument graphical 3D sub-model is aligned prior to the first graphical 3D computer model anatomy; One or more graphical 3D submodels of the structure are aligned, and this process determines the relative position between the graphical 3D submodel of the implant and / or surgical instrument and the graphical 3D submodel of the anatomical structure. 2 graphical 2D It is taken into account in the 3D computer model. Or
2) First, the graphical 3D submodel of the anatomy of the first graphical 3D computer model is aligned using the graphical 3D submodel of the anatomy of the second graphical 3D computer model, and then The graphical 3D submodel of the first graphical 3D computer model implant and / or surgical instrument is aligned using the second graphical 3D computer model implant and / or graphical instrument 3D submodel of the surgical instrument. The

  In an additional embodiment of the invention, step B) additionally includes the following substeps:

  Computer-aided planning and implementation of virtual surgical treatment of the anatomy to be treated using the first medical 3D image data set received in step A).

  Based on the first medical 3D image data set of the anatomy to be treated, a 3D submodel of the first graphical 3D computer model may be first established, which includes the anatomy and the initial graphical Used as a computer model for planning and implementation of virtual surgical treatment. Additional 3D submodels can then be established and integrated into the first graphical 3D computer model for completion of treatment, eg, for planned treatment steps such as bone fragment reduction.

  In yet another embodiment of the method, the first graphical 3D computer model is a graphical 3D submodel of the anatomy to be treated, and the first medical 3D image data set received in step A). Included in the form of a used digital data set.

In an additional embodiment of the method, the computer-aided planning includes the integration of at least one additional graphical 3D submodel of the first graphical 3D computer model implant. Thus, the location of implants and / or temporary aids such as, for example, guidewires, surgical tools or instruments can be spatially determined and expressed at each treatment step up to the completion of treatment. This is achieved by a comparison of the position of the corresponding 3D computer model of the implant and / or temporary, which is archived on a computer and, first, the (currently correct) anatomy (above) It can be downloaded with the 3D computer model (located in the location) and secondly with the location of the implant and / or temporary aid that can be visualized in the X-ray image . Thus, in this way, 3D computer models of implants and / or temporaries are available for various imaging such as traditional pre-operative X-ray images, intraoperative planar or spatial 3D C-arc images, or post-operative X-ray images. Through repeated registration using the process, it is always represented spatially throughout the course of treatment.

  In yet another embodiment of the method, the computer-aided planning includes integration of a temporary graphical 3D computer model, preferably at least one additional graphical 3D sub-model of the surgical instrument.

  In an additional embodiment of the method, the computer assisted planning includes assessing the biomechanical stability of an anatomical structure that has been surgically treated by computer simulation, preferably by finite element computer analysis. Is included. Through computer-aided analysis and planning of surgery, i.e. reduction of anatomy, the type and location of temporary and final implants can be virtually planned and spatially represented in a computer, Biomechanical stability can be assessed by computer simulation and re-evaluated at each treatment step. Depending on the condition, the treatment plan can then be continued or changed if necessary.

  In an additional embodiment of the method, the first graphical 3D computer model includes at least one graphical 3D submodel of at least one intermediate result of the anatomical structure that is virtually treated according to the computer-based planning. .

  In another embodiment of the method, the first graphical 3D computer model includes the implementation plan as a submodel, which defines the exact course of the surgical intervention and includes the corresponding administrative details. It is.

  The method can be used for surgical treatment monitoring. It is preferred that step C) of the method is first performed in a preoperative status, so that monitoring of at least one object is possible before a surgical intervention. Step C) of the method can be performed with at least one intraoperative status, so that at least one object can be monitored during the surgical procedure. Moreover, step C) can also be performed with at least one post-operative status, so that at least one object can be monitored after the surgical treatment.

  The method according to the invention is preferably used for quality assurance of surgical treatment. An additional component and advantage of the method is that all data generated throughout the course of treatment can be integrated and then analyzed in the quality control system. And in turn, this can have a positive effect on the type, selection and implementation of the treatment, for example, the treatment procedure can be standardized based on the relevant parameters.

  The method can be used in fracture treatment, bone misalignment treatment, and dental implant treatment.

  The invention and variants of the invention are described in more detail below with reference to partial drawing representations of some example embodiments.

Fig. 2 shows a flow chart of an embodiment of the method according to the invention. Fig. 6 shows a flow diagram of an additional embodiment of the method according to the invention. Fig. 3 shows a flow diagram of an embodiment of generation of a first graphical 3D computer model according to an embodiment of the method according to the invention according to Fig. 2;

  In principle, the method according to the invention can be used for any anatomical structure that can be acquired three-dimensionally by a computer-aided medical imaging process. In addition, it is possible to use any implant and intraoperatively usable surgical instrument that can be acquired, at least in part, in a geometrically unambiguous manner by means of a computer assisted medical imaging process.

Example 1:
In the following, the method according to the invention will be described as an example in surgical treatment of fractures and correction of bone misalignment.

  The difference between the embodiment represented in FIG. 1 and FIG. 2 is that, in the embodiment according to FIG. 1, the first graphical 3D computer model 1 of the anatomy to be treated is the first medical 3D image data before surgery. 2 is established based on the set 10, but in the embodiment according to FIG. 2, the first graphical only in that a graphical 3D computer model established similar to the embodiment according to FIG. 1 is used as the graphical 3D submodel. Generation of the 3D computer model 1 further includes computer assisted planning and implementation of virtual surgical treatment of anatomical structures to be treated using the 3D submodel. The embodiment of the method according to FIG. 1 can be used in particular when emergency computer-aided planning of surgery cannot be performed for time-related reasons, for example in a serious accident. In addition, in the embodiment of the method according to FIG. 2, all necessary pre-operative, intra-operative or post-operative image registrations for the monitoring of the whole course of treatment are compared with the embodiment according to FIG. 1 or the embodiment according to FIG. Can be implemented using.

  The embodiment of the method represented in FIG. 1 substantially includes the following steps.

Step 100: 3D Imaging Before Surgery Initially, reception of a first medical 3D image data set 10 prior to surgery of a patient's anatomy to be treated by a computer assisted medical imaging method. The method includes obtaining appropriate image information in the field of surgery prior to surgery. This is in preparation for the first medical 3D image data set of the patient, for example a pre-operative anatomical structure to be treated in a region with fracture or bone misalignment, preferably generated by CT. It is. Alternatively or additionally, other three-dimensional tomographic imaging methods such as cone beam tomography (also called digital volume tomography), magnetic resonance tomography, or 3D laser scanning may be used. As an output, a pre-operative first medical 3D image data set 10 is converted into a digitized 3D image data set in the form of, for example, a DICOM format (Digital Imaging and Communication in Medicine). Obtained at.

  Step 101: Generation of a first graphical 3D computer model 1 of the anatomy to be treated in the form of a digital data set using the first medical 3D image data set 10 received in step 100. In particular, this step identifies, identifies, and represents the anatomy before surgery is performed.

  The first preoperative medical 3D image data set 10, preferably generated by preoperative CT, is used to treat, for example, a bone fragment in the case of a fracture or a bone segment in the case of bone misalignment. The anatomical structure to be identified is identified and identified using suitable computer software and saved in the form of a first graphical 3D computer model 1, so that the structure is 3D bone fragment, for example on a monitor Can be expressed as This is the identification, for example, the recognition of the anatomical geometric pattern of the bone structure, for example the anatomical geometric pattern, the identification, the definition of the spatial position, and the representation, the spatial suitable as a 3D computer model. It can be done using methods of expression. This further includes image segmentation techniques. For example, in the case of corrective osteotomy, in this step 101, two or more virtual bone fragments have already been identified and identified according to the osteotomy plan, where the predicted cutting line is the bone fragment separation. Used for. Step 101 is performed automatically and / or manually at the computer prior to surgery, where a preoperative first medical 3D image data set 10 is received at step 100 as input and processing of this 3D data set is performed. That is, computer software and methods are used for identification, identification, and spatial representation of 3D anatomical structures such as, for example, bone fragments in the case of a fracture. As output, a processed digital data set is obtained, which allows for a graphical 3D representation of anatomical structures such as individual bone fragments, for example.

  The first graphical 3D computer model 1 of the anatomical structure to be acquired and treated in step 101 is matched with the second graphical 2D or 3D computer model 2 in terms of spatial position by image registration. This is generated from one or more digitized medical images of a second or additional medical 2D or 3D image data set 20 received before, during or after surgery. As a result, the first graphical 3D computer model 1 is computerized throughout the entire course of treatment at the updated location, ie the actual pre-operative, intra-operative or post-operative location of the anatomy to be treated. It can be expressed on the monitor. Thus, during the monitoring of surgical treatment, the first graphical 3D computer model 1 is treated pre-operatively in the operating room immediately prior to surgery, during surgery, after completion of surgery and / or post-operatively for follow-up. It can be used for the representation of the correct position of the power anatomy. For this reason, step 102 to step 104 described below are executed in each case.

  Alternatively (as described below in FIG. 2), the first medical 3D image received at step 200 is additionally included in the generation of the first graphical 3D computer model 1 described at step 201. Computer dataset planning and implementation of virtual surgical treatment of the anatomy to be treated using data set 10 may be included. For surgical treatment monitoring, the image registration of the first graphical 3D computer model 1 is in this case one of the second or additional medical 2D or 3D image data set 20 received before, during or after surgery. It can be performed according to one of the embodiments according to FIG. 1 or FIG. 2 using one or more digitized medical images.

  Step 102: Computer-assisted medical imaging prior to image registration of the first graphical 3D computer model 1 according to one of the embodiments according to FIG. 1 or FIG. 2 using a second graphical 2D or 3D computer model 2 Depending on the method, the reception of a second medical 2D or 3D image data set 20, including one or more digitized medical images 21, the anatomy to be treated, and / or the implant (desired pre-operative, intra-operative, Or done with postoperative status).

  Step 103: Next, a second graphical 2D or 3D of the anatomy to be treated in the form of a digital data set using the second medical 2D or 3D image data set 20 received in step 102. The computer model 2 is generated. For example, after receiving one or more digitized medical images by pre-, intra- or post-operative x-ray imaging of the anatomy to be treated, the same anatomical landmark of the anatomy, One or more digitized medical images or direct second graphical representations of bone fragments and bone contours of the fracture zone and healthy bone surface, including, for example, joint surfaces, bone tone values, and / or bone geometric patterns Re-identified and re-identified in 2D or 3D computer model 2 and then treated using a second graphical 2D or 3D computer model 2 in a pre-operative, intra-operative or post-operative state, eg bone fragments Align the first graphical 3D computer model 1 of the anatomy to be done. As a pre-, intra- or post-operative imaging technique, two conventional planar X-ray displays are used, or preferably by a 2D or 3D imaging process using a C-arc X-ray device. An X-ray image generated immediately before in the operating room is used.

  Step 104: Next, an image registration implementation of the first graphical 3D computer model 1 is performed using the second graphical 2D or 3D computer model 2. As a result, a new representation is created in which the first graphical 3D computer model 1 of the anatomy to be treated, for example a bone fragment, is visible in the correct position according to the current imaging. Since the acquisition of computed tomography (CT), for example, any deviations in the position of anatomical structures such as bone fragments are updated accordingly and corrected accordingly.

  The embodiment of the method represented in FIG. 2 is a virtual surgery of the anatomy to be treated if the generation of the first graphical 3D computer model 1 involves the use of implants and further surgical instruments. It differs from the embodiment depicted in FIG. 1 only in that it may include computer-aided planning and implementation of treatment.

  An embodiment of the method depicted in FIG. 2 is described using an example of osteosynthesis or orthodontic osteotomy, which includes substantially the following steps.

Step 200: 3D imaging before surgery:
Initially, similar to the embodiment according to FIG. 1, the reception of the first medical 3D image data set 10 before the operation of the patient's anatomy to be treated is carried out by a computer-aided medical imaging process. Is called.

  Step 201: Next, a first graphical 3D computer model 1 of the anatomy to be treated is generated in the form of a digital data set, where the generation of the first graphical 3D computer model 1 includes: Including computer-aided planning and implementation of virtual surgical treatment of the anatomy to be treated using the first medical 3D image data set 10 received in step 100. Similar to FIG. 1, in this step, the initial identification, identification and representation of the pre-operative anatomy is performed.

  Computer 3D pre-operative planning is represented in detail in FIG. 3, where the computer 3D pre-operative planning includes all or part of steps 2011 to 2021 represented in FIG. obtain. As an aid to the study of clinical documents, including evaluation of patient laboratory and imaging, preoperative planning of surgical interventions on computers will be additionally performed using appropriate software . Here, for example, in the case of a fracture, the anatomically correct virtual reduction of the 3D bone fragment represents the central task (step 2012). The anatomical reduction of 3D bone fragments further allows for the expression and analysis of the presence of any remaining bone defects. On the other hand, in the case of bone misalignment, osteotomy is substantially spatially established with the computer (step 2011), and then the 3D bone fragment is shifted to the planned position (step 2012). For this purpose, the 3D bone fragments established above are continuously re-presented or aligned according to the planned position of the osteotomy.

  As an additional function of this 3D pre-operative planning on the computer, a fracture or osteotomy can be virtually analyzed (step 2013). Thus, for example, the shape, size, and extent of bone dislocation, as well as any remaining or created defects, as well as possible overlap of bone fragments (important in osteotomy or bone grafting) can be calculated. . The process can also use known fracture classifications 4, such as AO COIAC classification or Muller AO classification, which can be saved and downloaded to a database.

  Then, in the case of a fracture and further bone misalignment, a virtual osteosynthesis (step 2016) is archived in the computer of surgical instruments and defined implants such as appropriately sized plates, bone marrow nails, screws, guide wires, etc. A stored temporary 3D computer model 5 can be selected and planned and placed in a first graphical 3D computer model, such as a graphical 3D submodel. In the case of a bone defect, the planning of self or artificial material (eg bone graft or cement), including quantity, additionally involves substantially a corresponding virtual filling material that matches the bone volume or mechanical properties It can be taken into account by expressing defects. As an additional function of step 201, an implementation plan (step 2017) is established and integrated as a sub-model of the first graphical 3D computer model 1, which defines the exact sequence of surgical interventions and Includes control details. Thus, a reduction order of bone fragments or osteotomy is established, as are the order and use of temporary and final implants. The management details include a virtual graphical 3D computer model of intermediate results, which can be compared with actual intermediate results during surgery.

  As an additional function of step 201, the osteosynthesis of bone fragments and implants created during virtual surgical planning can be substantially biomechanically tested, eg, by finite element analysis (step 2018).

As input, the preoperative first medical 3D image data set 10 received in step 200 is used, based on which a graphical 3D sub-section of the bone fragment or the entire region in case of bone misalignment before planning. A model can be created. The following software tools can be used for planning and performing virtual surgical treatment:
1. Software tools for generating virtual osteotomy, especially in case of bone misalignment,
2. Software tool for virtual reduction of 3D bone fragments,
3. Archived 3D computer templates for temporary and final implants such as plates, screws, bone marrow nails, Kirschner wires,
4). Software tools to analyze components (number of bone fragments and implants, size, shape, etc.) and planning process (eg degree of dislocation, angle of osteotomy) during planning,
5. Software tools for the main implementation plan and the establishment of alternatives,
6). Software tool for analysis of biomechanical properties of osteosynthesis.

  As output, a first graphical 3D computer model 1 is created, which includes an anatomical structure that is substantially surgically treated according to a computer-based planning including implants and / or surgical instruments, a computer-based planning One or more graphical 3D submodels of one or more intermediate results of an anatomical structure that are substantially surgically treated in accordance with, and computer-based planning of osteosynthesis for fracture treatment or correction of bone misalignment Can be included.

  Step 202: An anatomical structure to be treated that includes one or more digitized medical images 21 by a computer-assisted medical imaging method similar to FIG. 1 (in desired pre-operative, intra-operative or post-operative status) Receiving a second medical 2D or 3D image data set 20 of implants, and surgical instruments.

  Step 203: Similar to FIG. 1, the anatomy and / or implant to be treated in the form of a digital data set using the second 2D or 3D image data set 20 received in step 202. Generation of two graphical 2D or 3D computer models 2. For example, after one or more digitized medical images 21 have been generated by pre-, intra- or post-operative x-ray imaging of the anatomy to be treated with implants and / or surgical instruments, the anatomy One or more bone fragments and bone contours of the fracture zone and healthy bone surface, including anatomical landmarks of the anatomical structure, eg, joint surfaces, bone tone values, and / or bone geometric patterns Re-identified and rearranged with the digitized medical image 21 or directly with the second graphical 2D or 3D computer model 2, and then using the second graphical 2D or 3D computer model 2, the first graphical 3D computer Align Model 1 As a pre-operative imaging technique, two conventional planar X-ray images or two X-ray images are used, or preferably by a 2D or 3D imaging process using a C-arc X-ray machine. An X-ray image generated immediately before in the operating room is used.

  Step 204: Next, image registration of the first graphical 3D computer model 1 is performed using the second graphical 2D or 3D computer model 2. As in the case of image registration according to the embodiment according to FIG. 1, a new graphical representation is created, in which, for example, a first graphical 3D computer model 1 of the anatomy to be treated of a bone fragment is obtained. Visible at the correct position according to current imaging. Since the acquisition of computed tomography (CT), for example, possible deviations in the position of anatomical structures such as bone fragments are updated accordingly and corrected accordingly. As soon as the implants and / or surgical instruments become visible, either radiologically or in another imaging process, their position is graphical 3D using a graphical 3D submodel of an anatomical structure such as a bone fragment, for example. It can be spatially determined and represented by referring to the submodel. In addition, the entire planned implant, including the position and direction of insertion, as well as the final position can be visualized. Accordingly, in step 204, a temporary spatial and / or predicted spatial positioning of the final implant is also performed preoperatively. After alignment of all the described components, the various components can each be represented or masked on a computer.

The embodiment of the method according to the invention described in FIGS. 1 to 3 can then be used for three-dimensional (3D) monitoring of surgical treatments. In that process, 3D monitoring may include one or more of the steps listed below:
1) pre-operative monitoring and / or 2) intra-operative monitoring and / or 3) post-operative follow-up monitoring.

1) Monitoring before surgery:
Initially, according to step 102 or step 202, a second medical 2D or 3D image data set 20, eg, a preoperative x-ray image of the anatomy to be treated is received. Re-identify and re-identify anatomical landmarks in fracture zones and healthy bone surfaces, including joint surfaces, bone density values, and even bone geometric patterns in preoperative X-ray images And is aligned to the first graphical 3D computer model 1 of the bone fragment using the second graphical 2D or 3D computer model 2. As a pre-operative imaging technique, use conventional planar X-ray display or two-plane X-ray display, or even in the operating room immediately before surgery, preferably generated by 2D C arc or 3D C arc images X-ray images are also used.

  As a result, a new representation is created, in which, for example, a first graphical 3D computer model 1 of the anatomy of a bone fragment is visible in the correct position according to the current imaging. Any deviation in the position of the bone fragment from the time of CT acquisition is updated accordingly and corrected accordingly.

  Next, 3D surgical planning can be taken into account, ie the entire planned osteosynthesis construct can be visualized, including the position of the implant, the direction of insertion, and the final position. Thus, pre-spatial spatial positioning of the implant is also performed. After alignment of all the described components, the various components can each be represented on a computer or masked.

2) Monitoring during surgery:
A new X-ray image check is performed, but a 2D or 3D check is preferred during the next surgery. In the same manner, a new image registration is performed as described under step 204 above. Therefore, anatomical landmarks of fracture zones and healthy bone surfaces, including joint surfaces, bone tone values, and even bone geometric patterns, are re-identified and re-recognized in intraoperative X-ray images. Identified and registered to the first graphical 3D computer model 1 of the bone fragment. Thus, during surgery, the current position of the 3D bone fragment can be spatially determined and monitored. If the implant is attached to the bone at the beginning of the surgery, this can improve or facilitate the alignment process. This can be an advantage especially in orthopedic osteotomy. The reason is that less anatomical landmarks can be used here, as well as this can be identified in pre-operative 3D imaging as well.

  In the case of corrective osteotomy, it may be advantageous to perform only partial displacement first to spatially assess the position of the bone fragment by re-identification and re-identification. Moreover, measurements can then be initiated to improve the osteotomy results. The final attachment takes place only after checking the spatially correct position of the bone fragments.

  As soon as the implant and / or surgical instrument is visible through the course of the operation with an additional intraoperative X-ray image check, the spatial position is also already spatially defined in the graphical 3D computer model 1 and the implant and / or It can be determined by aligning using the corresponding positioning of the graphical 3D sub-model of the surgical instrument.

  Next, the 3D surgical planning according to step 201 may be taken into account again, i.e. the planned and current osteosynthesis, including the position of the implant and / or surgical instrument, the direction of insertion, the final position, is virtual. In addition, it can be visualized, analyzed and biomechanically tested.

  Moreover, by including X-ray checks with new re-identification and relocation during surgery and inclusion of information from pre-operative planning and simulation, surgeons continue to operate normally, document and modify in three dimensions, It can finally be completed using a check of the spatial location of the osteosynthesis.

  3) Monitoring at follow-up after surgery.

  Post-surgical follow-up with x-ray checks is performed according to regulations. In the X-ray check, the first graphical 3D computer model 1 of the bone fragment and the graphical 3D submodel of the post-osseous implant can also be re-identified and repositioned as needed. Thus, post-operative X-ray checks can determine if a change in the spatial location of a bone fragment or implant has been made, and in particular if the change has been made post-operatively. . Again, the location of the first graphical 3D computer model 1 of bone fragments and implants can be compared with the graphical 3D computer model 1 established before or during the operation. Computerized preoperative planning can be overlaid and the current state can be simulated, for example, by finite element analysis, to test the biomechanical stability of the current osteosynthesis. In further follow-up, a re-evaluation is performed, i.e. based on the expressed results of the decision to determine whether the treatment should be terminated or whether a new diagnosis or treatment step should be initiated. Is called.

  If accurate registration is successfully achieved with just a planar X-ray image, it is possible to dispense with standard “two-sided” X-ray document creation. Thus, exposure to radiation and costs can be reduced.

  One or more findings and results obtained during the embodiment of the method according to the invention represented in FIGS. 1 and 2 and the steps carried out during monitoring may be transferred to a surgical quality control system.

Example 2:
In the following, the method according to the invention represented in FIGS. 1 to 3 is represented in an additional example of the field of application of dental implantology. The course of treatment during the insertion of one or more dental implants can be monitored throughout the course of treatment as follows. Prior to surgery, 3D imaging of the surgical field and adjacent areas such as, for example, adjacent teeth and / or gums is performed, i.e. reception of the first medical 3D image data set 10 and the first one before surgery. 1 is generated (step 100 and step 101 in FIG. 1 and step 200 and step 201 in FIG. 2). It is advantageous that 3D imaging is performed by an optical 3D scanning method, for example laser scanning. This imaging can be performed alone or as a complement to preoperative CT or digital volume tomography. Individual treatment step monitoring includes the incorporation of preoperative, then intraoperative, and even surgical or dental prosthetic work (including surgical instruments such as pilot drills or dental implants) by optical laser scanning involving adjacent areas ( That is, it is done by acquiring the field of surgery immediately after the crown or bridge), and these imaging representations generated at various treatment stages are aligned. In addition to the second graphical 3D computer model, the 3D imaging display described above also forms an additional graphical 3D computer model 2, which in addition to the second medical 3D image data set, is an additional medical 3D image data set 20. 1 (step 102 and step 103 in FIG. 1 or step 202 and step 203 in FIG. 2) and registered using the first graphical 3D computer model 1 (step 104 in FIG. 1 or in FIG. 2). Step 204). This alignment is preferably performed on a structure that is not operated on with an anatomical structure such as, for example, a tooth or gum. Registration allows determination of the spatial position of the implant and surgical instrument. As described, a 3D pre-operative planning step (step 201 in FIG. 2) may be included in the treatment. Furthermore, the results of the entire treatment, eg, dental prosthetic treatment, can be compared with virtual planning or re-evaluated at any stage.

  The advantage of this variant of the invention is that the laser scanning is a 3D imaging process that does not produce X-rays. This laser scanning can be used and thus detected as soon as the surgical area as well as the implant segment, surgical instrument, as well as the fracture segment or the surface of the osteotomy become sufficiently visible. It is an advantage that no further exposure of the patient to x-rays occurs during the course of treatment. Moreover, a very detailed depiction of the surface, such as the surface of a tooth or implant, is also an advantage.

  Alternatively, however, in the field of dental implantology, as described, conventional dental x-ray displays can also be used to monitor over the course of treatment. In this case, although there is exposure to X-rays, it is minor. Because the implant or surgical instrument is located in the bone and / or under the mucous membrane and is not directly or fully detected by laser scanning, the implant or surgical instrument is not directly fully visible. If not, for example, a temporary body of known shape, such as a healing cap, can be attached to the implant or surgical instrument with a screw connection. If the operated area becomes scanned with the easily visible healing cap of each inserted implant, then the corresponding computer template of the healing cap is attached to the implant or surgical instrument Can be taken into account in the alignment with the computer template, and thus the position can also be clearly determined.

  As mentioned above, there are various embodiments of the present invention, but the various functions can be used either individually or in any desired combination.

  Accordingly, the present invention is not limited to the above-described particularly preferred embodiments.

Claims (28)

A method for generating a graphical 3D computer model of at least one anatomy with selectable pre-operative, intra-operative, or post-operative status comprising:
A) receiving a pre-operative first medical 3D image data set (10) of at least one anatomy to be treated by a computer assisted medical imaging process;
B) A first graphical 3D computer model (1) of the anatomy to be treated in the form of a digital data set using the first medical 3D image data set (10) received in step A). Generating step;
C) receiving a second medical 2D or 3D image data set (20) of the anatomy to be treated in a pre-operative, intra-operative or post-operative status by a computer-assisted medical imaging process;
D) A second graphical 2D or 3D computer model of the anatomy to be treated in the form of a digital data set using the second medical 2D or 3D image data set (20) received in step C). Generating (2);
E) performing an image registration process of the first graphical 3D computer model (1) using a second graphical 2D or 3D computer model (2). Step B)
The method according to claim 1, characterized in that it additionally comprises a sub-step of introducing a digital graphical 3D sub-model (1) that represents B1) the implant in a first graphical 3D computer model. Step B)
The method according to claim 1 or 2, characterized in that it further comprises the substep of B2) introducing a digital graphical 3D submodel (1) that represents the surgical instrument in a first graphical 3D computer model.   The first medical 3D image data set (10) received pre-operatively in step A) contains several anatomical structures, and a first graphical 3D computer model (1) 4. A method according to claim 2 or 3, characterized in that, for each implant and / or each surgical instrument, in each case a graphical 3D sub-model is included.   Method according to any one of the preceding claims, characterized in that the second graphical 2D or 3D computer model (2) additionally comprises a representation of one or more implants.   Method according to any one of the preceding claims, characterized in that the second graphical 2D or 3D computer model (2) additionally comprises a representation of one or more surgical instruments.   The anatomy and each implant, and preferably further the second graphical 2D or 3D computer model (2) of each surgical instrument, in each case comprises a 2D or 3D sub-model Item 7. The method according to Item 5 or 6.   The implementation of image registration, characterized in that the second graphical 2D or 3D computer model (2) forms a reference model in which the first graphical 3D computer model (1) matches. The method according to any one of 1 to 7.   In step C), receipt of the second medical 2D or 3D image data set (20) in pre-operative, intra-operative or post-operative status may be performed on one or more digitized medical images by a computer-assisted medical imaging process. 9. Method according to any one of claims 1 to 8, characterized in that it comprises reception.   Generation of the first graphical 3D computer model (1) comprises automatic or manual identification and identification of anatomical landmarks, lines and / or regions of the anatomy to be treated, 10. A method according to any one of claims 1-9.   The generation of the first graphical 3D computer model (1) comprises automatic or manual identification and placement of landmarks, lines and / or areas of each implant and preferably each surgical instrument Item 11. The method according to Item 10.   Anatomical landmarks, lines, and / or anatomical structures to be treated in which the generation of the second graphical 2D or 3D computer model (2) is identified and arranged in the first graphical 3D computer model (1) 12. Method according to any one of the preceding claims, characterized in that it comprises automatic or manual re-identification or rearrangement of regions.   Automatic generation of landmarks, lines, and / or regions for each implant and each surgical instrument whose generation of the second graphical 2D or 3D computer model (2) is identified and arranged in the first graphical 3D computer model (1) 13. The method of claim 12, comprising manual re-identification or relocation.   Step B) additionally adds a computer-aided planning and implementation sub-step of virtual surgical treatment of the anatomy to be treated using the first medical 3D image data set (10) received in step A) 14. A method according to any one of claims 1 to 13, characterized in that   A first graphical 3D computer model (1) is a graphical representation of the anatomy to be treated in the form of a digital data set using the first medical 3D image data set (10) received in step A). 15. A method according to claim 14, characterized in that it comprises a 3D submodel.   16. Method according to claim 14 or 15, characterized in that the computer-aided planning comprises the integration of at least one additional graphical 3D submodel of the implant of the first graphical 3D computer model (1).   17. Computer-aided planning, comprising the integration of a temporary graphical first model 3D computer model (1), preferably at least one additional graphical 3D sub-model of the surgical instrument. The method as described in any one of.   The computer-aided planning comprises an assessment of biomechanical stability of an anatomical structure that has been surgically treated by computer simulation, preferably substantially by finite element computer analysis. The method according to any one of 14 to 17.   The first graphical 3D computer model (1) comprises at least one graphical 3D submodel of at least one intermediate result of an anatomical structure virtually treated according to computer-based planning. The method according to any one of 14 to 18.   The first graphical 3D computer model (1) preferably includes an implementation plan (2017) as a sub-model that defines the exact course of the surgical intervention and includes the corresponding management details. 20. A method according to any one of claims 14 to 19.   21. A method for monitoring surgical treatment using the method of any one of claims 1-20.   The method according to claim 21, characterized in that step C) is performed in preoperative status, so that monitoring of at least one object prior to surgical treatment is possible.   23. A method according to claim 21 or 22, characterized in that step C) is performed with at least one intraoperative status, so that monitoring of at least one object during surgical treatment is possible.   24. A method according to any one of claims 21 to 23, characterized in that step C) is performed with at least one post-operative status, so that monitoring of at least one object after surgical treatment is possible. Method.   Use of the method according to any of claims 21 to 24 for quality assurance of surgical treatment.   Use of the method according to any one of claims 1 to 24 for the treatment of fractures.   Use of the method according to any one of claims 1 to 24 for the treatment of bone misalignment.   Use of the method according to any one of claims 1 to 24 in dental implantology.

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